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Clinical Trials and Studies

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1B-12-9: An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with Her2 Positive (Her2+) Metastatic Breast Cancer

Description

This is a multicenter, prospective, observational cohort study designed to follow patients with HER2+ MBC (Metastatic Breast Cancer) in the U.S. This observational cohort study (OCS) will provide important longitudinal follow-up of patients with HER2+ breast cancer across various stages to inform treatment strategy decision-making.The primary objective of this OCS is to describe temporal trends in treatment patterns as well as sequencing of treatments and clinical outcomes in patients with metastatic HER2+ breast cancer.A total of approximately 1000 patients will be enrolled out of which 20 will be enrolled at USC. Study duration subsequent to full accrual will be at least 5 years, ensuring a follow up of up to 8 years.Enrolled patients will have an initial diagnosis of HER2+ MBC that has not been previously treated with systemic therapy. They will receive treatment and evaluations for their HER2+ breast cancer as determined by their treating physicians, usually according to the standard of care and clinical practice at each study site.No treatment regimen will be protocol specified, and all treatments that patients receive for their HER2+ breast cancer will be collected. Participants will be asked to complete questionnaires at baseline and periodically throughout the study participation during site visits and at the time of disease progression to assess overall health status, activities of daily living, and other health issues. Patient-reported outcomes will be collected at baseline and periodically throughout study participation.An optional tissue and blood collection will be performed as part of this study.Primary endpoint is distribution of patients receiving unique treatment regimen or sequence of treatment regimens for HER2+ MBC.Secondary endpoints are:1. Progression-free survival (PFS)2. Overall Survival (OS)3. Post-progression survival (PPS) 4. Time to treatment failure (TTF)5. Response rate (RR)For descriptive summaries, continuous variables will be summarized using descriptive statistics. If applicable, analysis of variance (ANOVA)/model (t-test or F-test) or non-parametric testing such as Wilcoxon's rank sum test or Kruskal Wallis test will be used to test group difference on the continuous variables.Categorical variables will be summarized by numbers and proportions. If applicable, chi-square test will be used to test group difference on the categorical variables.

Phase

N/A

Inclusion and Exclusion Criteria

  • Adult patients, >/=18 years of age
  • Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
  • Availability of cancer-specific historical data points in the patient's medical records

  • Any inability to provide informed consent

Sites

  • California

    • Unknown facility, Burbank, California, 91505
    • Unknown facility, Los Angeles, California, 90095
    • Unknown facility, Fullerton, California, 92835
    • Unknown facility, Encinitas, California, 92008
    • Unknown facility, Palm Springs, California, 92262
    • Unknown facility, San Luis Obispo, California, 93454
    • Unknown facility, San Luis Obispo, California, 93401
    • Unknown facility, Fresno, California, 93710
    • Unknown facility, Fresno, California, 93720
    • Unknown facility, Campbell, California, 95008
    • Unknown facility, San Francisco, California, 94115
    • Unknown facility, Santa Rosa, California, 95403
  • Nevada

    • Unknown facility, Las Vegas, Nevada, 89148
  • Arizona

    • Unknown facility, Sedona, Arizona, 86336
    • Unknown facility, Tucson, Arizona, 85704
  • Utah

    • Unknown facility, Salt Lake City, Utah, 84112
    • Unknown facility, Ogden, Utah, 84403
  • Texas

    • Unknown facility, El Paso, Texas, 79915
    • Unknown facility, El Paso, Texas, 79915
    • Unknown facility, Fort Worth, Texas, 76104
    • Unknown facility, Bedford, Texas, 76022
    • Unknown facility, Waco, Texas, 76712
    • Unknown facility, Dallas, Texas, 75246
    • Unknown facility, Bryan, Texas, 77802
    • Unknown facility, Paris, Texas, 75460
    • Unknown facility, McAllen, Texas, 78503
    • Unknown facility, Tyler, Texas, 75701
    • Unknown facility, Houston, Texas, 77024
  • Colorado

    • Unknown facility, Denver, Colorado, 80210
    • Unknown facility, Denver, Colorado, 80205
    • Unknown facility, Denver, Colorado, 80220
  • Montana

    • Unknown facility, Missoula, Montana, 59802
    • Unknown facility, Billings, Montana, 59101
  • Washington

    • Unknown facility, Spokane, Washington, 99204
    • Unknown facility, Seattle, Washington, 98101
  • Idaho

    • Unknown facility, Post Falls, Idaho, 83854
  • Oklahoma

    • Unknown facility, Oklahoma City, Oklahoma, 73120
    • Unknown facility, Tulsa, Oklahoma, 74104
  • Nebraska

    • Unknown facility, Lincoln, Nebraska, 68510
    • Unknown facility, Omaha, Nebraska, 68106
  • Missouri

    • Unknown facility, Kansas City, Missouri, 64132
    • Unknown facility, Jefferson City, Missouri, 65109
    • Unknown facility, St Louis, Missouri, 63141
    • Unknown facility, St Louis, Missouri, 63136
  • Arkansas

    • Unknown facility, Rogers, Arkansas, 72758
    • Unknown facility, Hot Springs, Arkansas, 71913
    • Unknown facility, Little Rock, Arkansas, 72205
    • Unknown facility, Jonesboro, Arkansas, 72401
  • Iowa

    • Unknown facility, Ames, Iowa, 50010
    • Unknown facility, Mason City, Iowa, 50401
  • Minnesota

    • Unknown facility, Edina, Minnesota, 55435
    • Unknown facility, St Louis Park, Minnesota, 55416
    • Unknown facility, Minneapolis, Minnesota, 55407
  • Illinois

    • Unknown facility, Alton, Illinois, 62002
    • Unknown facility, Normal, Illinois, 61761
    • Unknown facility, Urbana, Illinois, 61801
    • Unknown facility, Park Ridge, Illinois, 60068
    • Unknown facility, Skokie, Illinois, 60076
    • Unknown facility, Chicago, Illinois, 60612
  • Louisiana

    • Unknown facility, Baton Rouge, Louisiana, 70809
  • Mississippi

    • Unknown facility, Jackson, Mississippi, 39202
  • Wisconsin

    • Unknown facility, Madison, Wisconsin, 53705
    • Unknown facility, Milwaukee, Wisconsin, 53211
  • Indiana

    • Unknown facility, Evansville, Indiana, 47714
  • Alabama

    • Unknown facility, Mobile, Alabama, 36604
    • Unknown facility, Birmingham, Alabama, 35205
  • Tennessee

    • Unknown facility, Nashville, Tennessee, 37203
    • Unknown facility, Chattanooga, Tennessee, 37404
  • Kentucky

    • Unknown facility, Louisville, Kentucky, 40202
    • Unknown facility, Louisville, Kentucky, 40207
  • Michigan

    • Unknown facility, Kalamazoo, Michigan, 49007
    • Unknown facility, Grand Rapids, Michigan, 49503
  • Ohio

    • Unknown facility, Middletown, Ohio, 45042
  • Georgia

    • Unknown facility, Marietta, Georgia, 30060
    • Unknown facility, Atlanta, Georgia, 30318
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